A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Metastatic or Advanced Solid Tumors (MAST).

This is an open-label, dose-escalation, multi-center phase I study evaluating the safety of CF33-hNIS (hNIS - human sodium iodide symporter) administered via two routes of administration, intratumoral (IT) or intravenous (IV), either as a monotherapy or in combination with pembrolizumab in patients with metastatic or advanced solid tumors.

开始日期2022-05-17

申办/合作机构

Imugene Ltd.

100 项与 VAXinia 相关的临床结果

登录后查看更多信息

100 项与 VAXinia 相关的转化医学

登录后查看更多信息

100 项与 VAXinia 相关的专利（医药）

登录后查看更多信息

项与 VAXinia 相关的文献（医药）

2023-06-15·Medical oncology (Northwood, London, England)

Current perspectives on Vaxinia virus: an immuno-oncolytic vector in cancer therapy.

Review

作者: Singh, Aman Deep ; Kapoor, Deepak N ; Kaur, Simran Deep

Viruses are being researched as cutting-edge therapeutic agents in cancer due to their selective oncolytic action against malignancies. Immuno-oncolytic viruses are a potential category of anticancer treatments because they have natural features that allow viruses to efficiently infect, replicate, and destroy cancer cells. Oncolytic viruses may be genetically modified; engineers can use them as a platform to develop additional therapy modalities that overcome the limitations of current treatment approaches. In recent years, researchers have made great strides in the understanding relationship between cancer and the immune system. An increasing corpus of research is functioning on the immunomodulatory functions of oncolytic virus (OVs). Several clinical studies are currently underway to determine the efficacy of these immuno-oncolytic viruses. These studies are exploring the design of these platforms to elicit the desired immune response and to supplement the available immunotherapeutic modalities to render immune-resistant malignancies amenable to treatment. This review will discuss current research and clinical developments on Vaxinia immuno-oncolytic virus.

2023-06-07·Molecular cancer therapeutics

An oncolytic poxvirus encoding hNIS, shows anti-tumor efficacy and allows tumor imaging in a liver cancer model.

Article

作者: Yang, Annie ; Chaurasiya, Shyambabu ; Warner, Susanne G ; Kim, Sang-In ; Valencia, Hannah ; Woo, Yanghee ; Lu, Jianming ; Fong, Yuman ; Zhang, Zhifang ; Ede, Nicholas J

Oncolytic viruses (OVs) are live viruses that can selectively replicate in cancer cells. We have engineered an OV (CF33) to make it cancer-selective through the deletion of its J2R (thymidine kinase) gene. Additionally, this virus has been armed with a reporter gene, human sodium iodide symporter (hNIS), to facilitate non-invasive imaging of tumors using positron emission tomography (PET). In this study we evaluated the oncolytic properties of the virus (CF33-hNIS) in liver cancer model, and its usefulness in tumor imaging. The virus was found to efficiently kill liver cancer cells and the virus-mediated cell death exhibited characteristics of immunogenic death based on the analysis of 3 damage associate molecular patterns (DAMPs): calreticulin, ATP and HMGB1. Furthermore, local or systemic administration of a single dose of the virus showed anti-tumor efficacy against a liver cancer xenograft model in mice and significantly increased survival of treated mice. Lastly, PET scanning was performed following injection of the radioisotope I-124, for imaging of tumors, and a single dose of virus as low as 1E03 pfu, administered intratumorally (I.T.) or intravenously (I.V.), allowed for PET imaging of tumors. In conclusion, CF33-hNIS is safe and effective in controlling human tumor xenografts in nude mice, and it also facilitates non-invasive imaging of tumors.

2023-04-01·Journal for ImmunoTherapy of Cancer

Development of the oncolytic virus, CF33, and its derivatives for peritoneal-directed treatment of gastric cancer peritoneal metastases

Article

作者: Chaurasiya, Shyambabu ; Kim, Sang-In ; Fong, Yuman ; Jung, Audrey ; Lu, Jianming ; Zhang, Zhifang ; Park, Anthony K ; Priceman, Saul ; Woo, Yanghee ; Yang, Annie

BackgroundGastric cancer (GC) that metastasizes to the peritoneum is fatal. CF33 and its genetically modified derivatives show cancer selectivity and oncolytic potency against various solid tumors. CF33-hNIS and CF33-hNIS-antiPDL1 have entered phase I trials for intratumoral and intravenous treatments of unresectable solid tumors (NCT05346484) and triple-negative breast cancer (NCT05081492). Here, we investigated the antitumor activity of CF33-oncolytic viruses (OVs) against GC and CF33-hNIS-antiPDL1 in the intraperitoneal (IP) treatment of GC peritoneal metastases (GCPM).MethodsWe infected six human GC cell lines AGS, MKN-45, MKN-74, KATO III, SNU-1, and SNU-16 with CF33, CF33-GFP, or CF33-hNIS-antiPDL1 at various multiplicities of infection (0.01, 0.1, 1.0, and 10.0), and performed viral proliferation and cytotoxicity assays. We used immunofluorescence imaging and flow cytometric analysis to verify virus-encoded gene expression. We evaluated the antitumor activity of CF33-hNIS-antiPDL1 following IP treatment (3×105pfu × 3 doses) in an SNU-16 human tumor xenograft model using non-invasive bioluminescence imaging.ResultsCF33-OVs showed dose-dependent infection, replication, and killing of both diffuse and intestinal subtypes of human GC cell lines. Immunofluorescence imaging showed virus-encoded GFP, hNIS, and anti-PD-L1 antibody scFv expression in CF33-OV-infected GC cells. We confirmed GC cell surface PD-L1 blockade by virus-encoded anti-PD-L1 scFv using flow cytometry. In the xenograft model, CF33-hNIS-antiPDL1 (IP; 3×105pfu × 3 doses) treatment significantly reduced peritoneal tumors (p<0.0001), decreased amount of ascites (62.5% PBS vs 25% CF33-hNIS-antiPDL1) and prolonged animal survival. At day 91, seven out of eight mice were alive in the virus-treated group versus one out of eight in the control group (p<0.01).ConclusionsOur results show that CF33-OVs can deliver functional proteins and demonstrate effective antitumor activity in GCPM models when delivered intraperitoneally. These preclinical results will inform the design of future peritoneal-directed therapy in GCPM patients.

项与 VAXinia 相关的新闻（医药）

2024-07-01

·PRNewswire

Oncolytic Viruses: Unlocking a New Era in Cancer Immunotherapy | DelveInsight

The potential of oncolytic viruses as a novel approach to cancer treatment is exciting and offers a targeted approach that holds promise for overcoming treatment resistance and achieving durable responses in a range of malignancies. LAS VEGAS, July 1, 2024 /PRNewswire/ -- Oncolytic viruses are either RNA or DNA viruses. RNA viruses such as reoviruses, paramyxoviruses, and picornaviruses, which encode only a few genes, often undergo rapid proliferation and lysis of tumor cells. On the other hand, oncolytic DNA viruses such as herpes viruses, adenoviruses, or poxviruses allow for the insertion of multiple foreign genes but are slower in replication and amplification. Among the selected cancers, bladder cancer accounted for the maximum cases as compared to other selected indications in 2023 among the 7MM. As per the DelveInsight assessment, in 2023, the total incident cases of melanoma, non-melanoma skin cancer, pancreatic cancer, renal cell carcinoma, prostate cancer, brain cancer, bladder cancer, and ovarian cancer combined in the United States were 1.1 million. Currently, only two oncolytic virus therapies are approved, namely, IMLYGIC (Talimogene laherparepvec/T-VEC; Amgen) and DELYTACT (teserpaturev/G47∆; Daiichi Sankyo). Learn more about the FDA-approved oncolytic viruses @ Oncolytic Viruses Cancer Treatment IMLYGIC (T-VEC), developed by Amgen, became the first oncolytic virus to receive approval from the FDA in 2015. It is indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with recurrent melanoma following initial surgery. Subsequently, in December 2015, the European Commission (EC) also approved for its use in treating adults with unresectable melanoma that has regionally or distantly metastasized (Stage IIIB, IIIC, and IVM1a), excluding bone, brain, lung, or other visceral diseases. This genetically modified herpes simplex virus type 1 is engineered to replicate within tumors and express an immune-stimulating protein known as granulocyte-macrophage colony-stimulating factor (GM-CSF). DELYTACT (G47Δ) is a modified form of herpes simplex virus type 1 (HSV-1) with three mutations, designed to selectively replicate within cancer cells. In 2021, it received provisional approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for hospital-based commercialization, specifically for treating malignant glioma patients over 7 years. This approval followed a Phase II trial demonstrating improved one-year survival rates among patients with recurrent glioblastoma, previously treated with radiotherapy and temozolomide chemotherapy. DELYTACT marks the world's first oncolytic virus therapy for brain cancer and only the third globally available oncolytic virus treatment. To learn more about oncolytic viruses cancer treatment options, visit @ Oncolytic Virus Cancer Therapy The field of oncolytic virus therapy is still developing. Further research is needed to determine their long-term efficacy and potential challenges. Still, early results seem encouraging, suggesting that oncolytic viruses may become a powerful tool for the treatment of patients with cancer. Presently, oncolytic virus therapy is only approved for melanoma and malignant glioma (in Japan). However, the pipeline suggests its emergence as a potential treatment for various cancers, including ovarian cancer, non-small cell lung cancer, breast cancer, renal cell carcinoma, and others. The pipeline for oncolytic viruses is robust, with major pharmaceutical companies such as Replimune (RP1), Genelux (Olvi-Vec), Candel Therapeutics (CAN-2409), Imugene (CF33-HNIS), EpicentRx (AdAPT-001), and others actively engaged in research to enhance cancer treatment options. Discover which therapies are expected to grab major oncolytic virus therapy market share @ Oncolytic Virus Therapy Market Report Olvi-Vec is a proprietary oncolytic vaccinia virus engineered to enhance safety, tumor selectivity, and therapeutic potential. Originally a non-human pathogen used in the smallpox vaccine, the vaccinia virus induces immunogenic cell death and activates the immune system for long-term cancer immunotherapy. According to Genelux's recent corporate presentation, topline results for the Phase III OnPrime/GOG-3076 study are expected in the second half of 2025. In November 2023, Genelux announced that the US FDA granted Fast Track Designation for Olvi-Vec (olvimulogene nanivacirepvec) in treating patients with platinum-resistant/refractory ovarian cancer. The drug is currently in Phase III clinical development, with the study anticipated to be completed by 2026. RP1 is Replimune's leading product candidate, developed from a proprietary new strain of herpes simplex virus. It has been genetically modified and enhanced with a fusogenic protein (GALV-GP R-) and GM-CSF to enhance tumor-killing potency, improve the immunogenicity of tumor cell death, and stimulate a systemic anti-tumor immune response. In April 2024, Replimune presented interim results from ARTACUS, a Phase I/II clinical trial testing RP1 monotherapy for skin cancers in patients who have undergone solid organ or hematopoietic cell transplants. Currently, RP1 is in the Phase II IGNYTE study, a multi-cohort clinical trial combining RP1 with OPDIVO. AdAPT-001 is an experimental immunotherapy featuring a TGF-β receptor-immunoglobulin Fc fusion trap. It is designed to neutralize isoforms 1 and 3 of the profibrotic, proangiogenic, prohypoxic, and immunosuppressive cytokine, TGF-β, and make resistant tumors more responsive to checkpoint blockade. In the ongoing Phase I/II BETA PRIME trial, AdAPT-001 is being administered alone and in combination with checkpoint inhibitors to patients with treatment-resistant tumors. Notably, AdAPT-001 combined with checkpoint inhibitors has shown improved toxicity and adverse event profiles compared to the typical results seen with checkpoint inhibitors alone. Discover more about oncolytic viruses in development @ Oncolytic Viruses Cancer Therapy Clinical Trials The anticipated launch of these emerging therapies are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the oncolytic virus cancer therapy market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for oncolytic virus therapy is expected to grow with a significant CAGR by 2034. As per DelveInsight, the United States accounts for the largest oncolytic virus market size accounting for more than 70% of the total market, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan. Among all the emerging oncolytic virus therapies, RP1 is the most promising therapy accounting for ~40% of the oncolytic virus market in the coming decade due to its high efficacy. DelveInsight's latest published market report titled as Oncolytic Virus Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the oncolytic virus country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The oncolytic virus market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Selected Cancer Types Target Patient Pool of Oncolytic Virus Cancer Therapy by Cancer Types Total Treated Cases by Line of Therapies The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM oncolytic virus market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this oncolytic virus market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the oncolytic virus market. Also, stay abreast of the mitigating factors to improve your market position in the oncolytic virus therapeutic space. Related Reports Oncolytic Virus Competitive Landscape Oncolytic Virus Competitive Landscape – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key oncolytic virus companies, including Genelux Corporation, Candel Therapeutics, CG Oncology, DNAtrix, SillaJen Biotherapeutics, Oncolytics Biotech, Wuhan Binhui Biotechnology, Oryx GmbH, Jiangsu Sinorda Biomedicine Co., Ltd, Virogin Biotech, Replimune, Viralytics, Oncolys Biopharma, Istari Oncology, Immvira Pharma, Seneca Therapeutics, Treovir, LLC, Targovax, Lokon Pharma, ORCA Therapeutics, Beijing SyngenTech, ViruCure, Tasly Pharmaceuticals, Turnstone Biologics, BioInvent, Transgene, Elicera Therapeutics, Orgenesis, Virttu Biologics, Imugene, Astellas Pharma, Wuhan Binhui Biotechnology Co., Ltd., Mustang Bio, Virogin Biotech, Vaxiion Therapeutics, ImmVirX, Memgen, Replimune, Immvira Pharma, ViroCure, GeneMedicine, PsiOxus Therapeutics, VCN Biosciences, Candel therapeutics, Sorrento Therapeutics, Imugene Limited, Calidi Biotherapeutics, Replimune, TILT Biotherapeutics, Guangzhou Virotech Pharmaceutical, DNAtrix, Oncorus, BioEclipse Therapeutics, among others. Oncology Drugs Market Oncology Drugs Market Insight, Competitive Landscape, and Market Forecast – 2030 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key oncology drugs companies, including GlaxoSmithKline, Eli Lilly & Company, F. Hoffmann-La Roche Ltd, AbbVie Inc., Amgen Inc, Sanofi, Merck & Co., Inc, Novartis AG, Pfizer Inc, AstraZeneca, Bristol Myers Squibb., Gilead Sciences, Inc., Janssen Global Services, LLC, BAYER AG., Celldex Therapeutics Inc., Alaunos Therapeutics, Inc., Astellas Pharma Inc., Genentech, Inc., Sandoz International GmbH, BeiGene, among others. Melanoma Market Melanoma Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key melanoma companies including IO Biotech, Merck Sharp & Dohme, Eisai, Regeneron Pharmaceuticals, Iovance Biotherapeutics, Highlight Therapeutics, Linnaeus Therapeutics, Spring Bank Pharmaceuticals, Taiga Biotechnologies, Inc., Aivita Biomedical, Inc., Genentech, Inc., Dana-Farber Cancer Institute, BioMed Valley Discoveries, Inc, Amgen, Checkmate Pharmaceuticals, Astellas Pharma Inc, Galectin Therapeutics Inc., Eucure (Beijing) Biopharma Co., Ltd, Mologen AG, Ultimovacs ASA, Seagen Inc., MedImmune LLC, OnKure, Inc., Syntrix Biosystems, Inc., Anaveon AG, iOx Therapeutics, Portage Biotech, ModernaTX, Inc., Nektar Therapeutics, BioNTech SE, Sapience Therapeutics, HUYABIO International, LLC., Provectus Biopharmaceuticals, Inc., Cantargia AB, Turnstone Biologics, Corp., Aura Biosciences, F-star Therapeutics, Inc., Day One Biopharmaceuticals, Inc., Kinnate Biopharma, Xencor, Inc., HiFiBiO Therapeutics, among others. Pancreatic Cancer Market Pancreatic Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pancreatic cancer companies including FibroGen, OSE Immunotherapeutics, Lokon Pharma, Oncotelic Inc., Tesaro, Inc., Helix BioPharma Corporation, Theradex, Tvardi Therapeutics, Incorporated, AIM ImmunoTech Inc., BioNTech SE, Prestige Biopharma Limited, HCW Biologics, Cantex Pharmaceuticals, XBiotech, Inc., Lumicell, Inc., CARsgen Therapeutics Co., Ltd., Panbela Therapeutics, Inc. , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

临床2期临床3期临床结果免疫疗法快速通道

2024-04-15

·BioSpace

Bile Tract Cancer expansion study opens following clearance of Imugene’s MAST trial high dose cohort

The expansion trial is expected to enrol 10 patients with bile tract cancers (cholangiocarcinoma) Interim results from the MAST trial have demonstrated positive responses in gastrointestinal cancers, particularly in cholangiocarcinoma where one patient treated with CF33-hNIS (VAXINIA) achieved a complete response and another patient achieved stable disease The fifth cohort in the intratumoural (IT) arm of the VAXINIA monotherapy trial has now been cleared with no safety signals seen to date; the cohort included patients with thymic carcinoma, triple negative breast cancer and cholangiocarcinoma SYDNEY, Australia, April 15, 2024 (GLOBE NEWSWIRE) -- Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to announce that enrolment has opened for its expansion study in bile tract cancer (cholangiocarcinoma) patients, having completed the fifth, high dose cohort in the intratumoural (IT) arm of the monotherapy dose escalation study evaluating its cancer-killing virus CF33-hNIS (VAXINIA). Imugene Managing Director & CEO Leslie Chong said: “As a team we’re particularly eager to begin the cholangiocarcinoma expansion study, given the meaningful difference we’ve seen VAXINIA make for patients with gastrointestinal cancers, including one patient with cholangiocarcinoma who achieved a complete response and another who achieved stable disease. It’s timely for enrolment to open as we present our VAXINIA technology to the 2024 Cholangiocarcinoma Foundation Annual Conference later this week.” The expansion of the MAST (Metastatic Advanced Solid Tumours) Phase 1 trial is planned for 10 patients with bile tract cancers, after early positive responses were observed in gastrointestinal cancers, particularly in cholangiocarcinoma. Cholangiocarcinoma is a rare disease in which malignant cancer cells form in the bile ducts. It is difficult to treat and generally responds poorly to immunotherapy drugs. One patient with cholangiocarcinoma who had failed three prior lines of therapy received a mid-dose of IT-administered monotherapy VAXINIA achieved a complete response, meaning the disappearance of all signs of cancer in response to treatment, with no known recurrence in more than 430 days. A second patient with cholangiocarcinoma, who has also progressed on prior drug therapies, achieved stable disease for more than four months upon receiving IV-administered VAXINIA. In November 2023, the FDA granted the VAXINIA MAST clinical program Fast Track Designation for the treatment of bile duct cancer (cholangiocarcinoma), which allows Imugene closer cooperation with the FDA to expedite the program and potential approval process. This designation followed the promising data detailing Phase 1 efficacy and tolerability. On Friday 12 April 2024, the Cohort Review Committee cleared the fifth cohort in the IT arm of the monotherapy dose escalation portion of the MAST trial, with no safety signals seen to date. In addition to the patients dosed in the monotherapy dose escalation portion of the trial, enrolment is ongoing for the VAXINIA and pembrolizumab combination portion of the trial, with 16 patients dosed to date. The multicenter, Phase 1, MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. With no safety signals identified to date, the trial has since progressed through the monotherapy dose escalation cohorts as well as the combination study, whereby VAXINIA is administered with well-known checkpoint inhibitor pembrolizumab. CF33 oncolytic virus, developed by City of Hope, has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models¹. Further dose escalation to continue as long as no safety issues are observed For more information please contact: Leslie Chong Managing Director and Chief Executive Officer info@imugene.com Investor Enquiries shareholderenquiries@imugene.com US Investor and Media Enquiries Heather Armstrong harmstrong@imugene.com Media Enquiries Matt Wright matt@nwrcommunications.com.au Connect with us on LinkedIn @Imugene Limited Follow us on Twitter @TeamImugene Watch us on YouTube @ImugeneLimited References ¹ Warner SG, Kim SI, Chaurasiya S, O'Leary MP, Lu J, Sivanandam V, Woo Y, Chen NG, Fong Y. A Novel Chimeric Poxvirus Encoding hNIS Is Tumor-Tropic, Imageable, and Synergistic with Radioiodine to Sustain Colon Cancer Regression. Mol Ther Oncolytics. 2019 Apr 11;13:82-92. doi: 10.1016/j.omto.2019.04.001. PMID: 31061881; PMCID: PMC6495072. About Imugene (ASX:IMU) Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours. Our unique platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Our pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) which targets CD19 to treat blood cancers. Our pipeline also includes multiple immunotherapy B-cell vaccine candidates and an oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies such as CAR T’s for solid tumours. We are supported by a leading team of international cancer experts with extensive experience in developing new cancer therapies with many approved for sale and marketing for global markets. Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer-reviewed research. Imugene is well funded and resourced, to deliver on its commercial and clinical milestones. Together with leading specialists and medical professionals, we believe Imugene’s immuno-oncology therapies will become foundation treatments for cancer. Our goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market. Release authorised by the Managing Director and Chief Executive Officer Imugene Limited. A photo accompanying this announcement is available at Imugene’s Phase 1 CF33-hNIS (VAXINIA) MAST Trial Enrolment has opened for Imugene’s expansion study in bile tract cancer (cholangiocarcinoma) patients, having completed the fifth, high dose cohort in the intratumoural (IT) arm of the monotherapy dose escalation study.

临床结果免疫疗法临床1期快速通道

2024-04-09

·GlobeNewswire-Health Care

Imugene's oncolytic virotherapy VAXINIA and B cell immunotherapy HER-Vaxx featured at the AACR Annual Meeting 2024

Oncolytic virus CF33-hNIS (VAXINIA) alone or in combination with KEYTRUDA is a safe treatment option for advanced cancer patients.Encouraging VAXINIA efficacy, including a complete response (CR) and two partial responses (PRs), has warranted cohort expansions in biliary tract cancer and other tumour types.Compared to chemotherapy alone, vaccination with HER-Vaxx was associated with a 40% overall survival benefit.HER-Vaxx induced HER2-specific antibody levels correlate with tumour reduction. SYDNEY, Australia, April 09, 2024 (GLOBE NEWSWIRE) -- Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to announce poster presentations featuring its CF33 oncolytic virotherapy VAXINIA and B cell immunotherapy HER-Vaxx at the American Association for Cancer Research (AACR) Annual Meeting 5-10 April 2024, in San Diego, CA. Daneng Li, M.D., a City of Hope associate professor in the Department of Medical Oncology & Therapeutics Research commented, “The results show that our novel oncolytic virus — both alone or in combination with immunotherapy — has the ability to control various cancer types previously resistant to other treatment options, and these early results provide patients with hope of a new treatment option for cancers refractory to standard treatment.” Imugene Managing Director & CEO Leslie Chong said: "Preliminary data from the MAST trial demonstrates encouraging anti-tumour activity with our oncolytic virus CF33-hNIS (VAXINIA). Notably, one patient with cholangiocarcinoma, or biliary tract cancer, achieved an immunological complete response (CR), meaning the disappearance of all signs of their cancer after treatment with VAXINIA, with no known recurrence after one year. These encouraging results warrant further investigation in patients will biliary tract cancer and other cancers. In addition, further analysis of the T cell repertoire reveals that T cell diversity may serve a predictive biomarker, which can be used to prospectively identify appropriate patients for treatment.” Details on the poster presentations are below: Presentation Title: Oncolytic virus CF33-hNIS for the treatment of advanced cancerAbstract Presentation Number: CT182Session Date and Time: Tuesday April 9, 2024, 9:00 AM - 12:30 PM PTSession Title: First-in-Human Phase I Clinical Trials 2Presenter: Daneng Li, MD Highlights include: At the data cut-off of 19 December 2023, there were 31 efficacy-evaluable patients in the MAST study. In the intratumoural (IT) cohorts, 7 of 16 (44%) injected lesions had a reduction in tumour burden and 3 lesions were completely eradicated. Three of the IT treated patients had an objective response: 1 complete response by iRECIST in a patient with cholangiocarcinoma and 2 partial responses by RECIST in patients with melanoma. In the intravenous (IV) cohorts, 9 of 17 (53%) patients achieved stable disease as their best response. Patients who received prior checkpoint blockade therapy derived clinical benefit with and without pembrolizumab. Viral replication, assessed by SPECT, was higher in patients who had a reduction in tumour burden.Patients with a higher level of T cell diversity in peripheral blood (pre-treatment) respond better to VAXINIA therapy, consistent with the known mechanism of action of oncolytic virotherapies and their ability to promote an anti-tumour T cell response.Both IT- and IV-treated patients have promising immunological changes in on-treatment tumour biopsies (including increases in cancer fighting CD8 T cells and PD-L1 expression) indicated that VAXINIA can transform the tumour microenvironment.Several patients have had prior treatment with checkpoint blockade, including a stable disease cholangiocarcinoma patient and two melanoma partial response patients. This suggests that VAXINIA +/- checkpoint inhibitor combination could be used in the checkpoint therapy refractory setting, which is seeing a growing and unmet market in oncology, by altering the tumour microenvironment. Presentation Title: Frontline vaccination with the B-cell peptide compound HER-Vaxx (IMU-131), combined with standard-of-care chemotherapy induces high levels of HER2-specific antibodies mediating ADCC and intracellular phosphorylation inhibition resulting in overall survival benefit in patients with HER2+ metastatic or advanced gastric/GEJ adenocarcinoma – Final results from Phase II/HERIZON studyPoster Number: CT215Session Date and Time: Tuesday April 9, 2024, 9:00 AM - 12:30 PM PTSession Title: Phase II Clinical Trials 1Presenter: Joshua Tobias Ph.D. Highlights include: HER-Vaxx treatment produced robust anti-HER2-IgG and IgG1 antibody response (p<0.001).HER-Vaxx induced HER2-specific antibodies able to mediate antibody-dependent cell cytotoxicity (ADCC) and inhibit intracellular HER2 phosphorylation and correlated with tumour reduction.The HER-Vaxx induced HER2-specific antibodies demonstrate a similar mechanism of action to HERCEPTINâ validating B cell immunotherapy as an alternative anti-cancer agent to monoclonal antibodies. About the MAST TrialThe multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to patients with metastatic or advanced solid tumours who have had at least two prior lines of standard of care treatment. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical laboratory and animal models¹. Overall, the study aims to recruit cancer patients across approximately 10 trial sites in the United States and Australia. The clinical trial is titled “A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33- hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid Tumours (MAST).” The trial commenced in May 2022 and is anticipated to run for approximately 24 months while being funded from existing budgets and resources. Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484. For more information please contact: Leslie ChongManaging Director and Chief Executive Officerinfo@imugene.com Investor Enquiriesshareholderenquiries@imugene.com U.S Investor EnquiriesHeather Armstrongharmstrong@imugene.com Media EnquiriesMatt Wright matt@nwrcommunications.com.au Connect with us on LinkedIn @Imugene Limited Follow us on Twitter @TeamImugene Watch us on YouTube @ImugeneLimited Join us on InvestorHub; investorhub.imugene.com About Imugene (ASX:IMU) Imugene is a clinical stage immuno-oncology company developing a range of new and novel immunotherapies that seek to activate the immune system of cancer patients to treat and eradicate tumours. Our unique platform technologies seek to harness the body’s immune system against tumours, potentially achieving a similar or greater effect than synthetically manufactured monoclonal antibody and other immunotherapies. Our pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel (azercabtagene zapreleucel) which targets CD19 to treat blood cancers. Our pipeline also includes multiple immunotherapy B-cell vaccine candidates and an oncolytic virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies such as CAR T’s for solid tumours. We are supported by a leading team of international cancer experts with extensive experience in developing new cancer therapies with many approved for sale and marketing for global markets. Our vision is to help transform and improve the treatment of cancer and the lives of the millions of patients who need effective treatments. This vision is backed by a growing body of clinical evidence and peer-reviewed research. Imugene is well funded and resourced, to deliver on its commercial and clinical milestones. Together with leading specialists and medical professionals, we believe Imugene’s immuno-oncology therapies will become foundation treatments for cancer. Our goal is to ensure that Imugene and its shareholders are at the forefront of this rapidly growing global market. Release authorised by the Managing Director and Chief Executive Officer Imugene Limited.

临床结果免疫疗法临床1期AACR会议临床2期

100 项与 VAXinia 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
晚期恶性实体瘤	临床1期	美国	Imugene Ltd.	2022-05-17
晚期恶性实体瘤	临床1期	澳大利亚	Imugene Ltd.	2022-05-17
胆管癌	临床1期	澳大利亚	Imugene Ltd.	2022-05-17
胆管癌	临床1期	美国	Imugene Ltd.	2022-05-17
转移性实体瘤	临床1期	美国	Imugene Ltd.	2022-05-17
转移性实体瘤	临床1期	澳大利亚	Imugene Ltd.	2022-05-17
肿瘤转移	临床1期	澳大利亚	Imugene Ltd.	2022-05-17
肿瘤转移	临床1期	美国	Imugene Ltd.	2022-05-17
转移性乳腺癌	临床1期	美国	Imugene Ltd.	2021-10-18
转移性三阴性乳腺癌	临床1期	美国	Imugene Ltd.	2021-10-18

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05346484 (MAST, AACR2024) 人工标引	临床1期	晚期癌症	36	CF33-hNIS	(鏇鹹遞憲願網鬱鏇構網) = such as grade 1/2: fatigue (31%), pyrexia (22%), and chills (14%) 蓋鑰淵鑰淵遞鏇鏇鏇鏇 (構鏇鹹鏇廠觸鏇獵築鹽 ) 更多	积极	2024-04-05
NCT05346484 (MAST, NEWS) 人工标引	临床1期	实体瘤	7	CF33	(觸鏇窪艱齋鑰齋簾鬱鑰) = 窪廠選積選鏇衊糧觸繭鬱齋構構築齋簾願糧壓 (遞鹹願鑰鬱鹹築觸餘鏇 ) 更多	积极	2024-01-18